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1 Research on Heroin NN0023

2 Research on Heroin NN0023

3 Introduction The National Institute on Drug Abuse (NIDA) supports most of the world s research on drug abuse and addiction. NIDA-funded research enables scientists to apply the most advanced techniques available to the study of every aspect of drug abuse, including: genetic and social determinants of vulnerability and response to drugs; short- and long-term effects of drugs on the brain, including addiction; other health and social impacts of drug abuse, including infectious diseases and economic costs; development and testing of medication and behavioral treatments for abuse and addiction; and development and evaluation of effective messages to deter young people, in particular, from abusing drugs. Included in this document are selections of topic-specific articles reprinted from NIDA s research newsletter, NIDA NOTES. Six times per year, NIDA NOTES reports on important highlights from NIDA-sponsored research, in a format that specialists and lay readers alike can read and put to use. Selections like the current one are intended to remind regular NIDA NOTES readers and inform other readers of important research discoveries during the periods they cover. We hope the information contained here answers your needs and interests. To subscribe to NIDA NOTES and for further information on NIDA s drug abuse and addiction research, please visit our Web site at ii

4 Table of Contents Once-A-Month Medication for Heroin Addiction? (V19-3; September 2004) Successful Trial Caps 25-Year Buprenorphine Development Effort (V19-3; September 2004) Researchers Adapt HIV Risk Prevention Program for African-American Women (V19-1; April 2004)....5 New Approaches Seek To Expand Naltrexone Use in Heroin Treatment (V17-6; March 2003) Opening the Door to Mainstream Medical Treatment of Drug Addiction (V17-5; January 2003) Buprenorphine Approval Expands Options for Addiction Treatment (V17-4; November 2002) Combining Medications May Be Effective Treatment for Speedball Abuse (V17-3; October 2002) High-Risk Sex Is Main Factor in HIV Infection for Men and Women Who Inject Drugs (V17-2; May 2002) Buprenorphine Taken Three Times per Week Is as Effective as Daily Doses in Treating Heroin Addiction (V16-4; October 2001) Year Study Finds Lifelong, Lethal Consequences of Heroin Addiction (V16-4; October 2001) Buprenorphine Proves Effective, Expands Options For Treatment of Heroin Addiction (V16-2; May 2001) Nicotine Craving and Heavy Smoking May Contribute to Increased Use of Cocaine and Heroin (V15-5; October 2000) Drug Abuse Treatment Programs Make Gains in Methadone Treatment and HIV Prevention (V15-3; August 2000) Recovery Harder for Addicts Who Start Young (V14-6; March 2000) High-Dose Methadone Improves Treatment Outcomes (V14-5; December 1999) Heroin Snorters Risk Transition To Injection Drug Use And Infectious Disease (V14-2; August 1999) Linking Medical Care With Drug Abuse Treatment Stems Tuberculosis Among HIV-Infected Drug Users (V13-3; July 1998) iii

5 Research Findings Volume 19, Number 3 (September 2004) Once-A-Month Medication for Heroin Addiction? By Kimberly R. Martin, NIDA NOTES Contributing Writer A single injection of a new sustainedrelease formulation of buprenorphine substantially blocked heroin s effects and relieved heroin craving and withdrawal symptoms for up to 6 weeks, report researchers at the Behavioral Pharmacology Research Unit at The Johns Hopkins University School of Medicine in Baltimore. The study, the first to test sustainedrelease buprenorphine in human opioid addicts, affirms the promise of a formulation designed to increase patient adherence to treatment, ease the burden of visits to treatment providers, and reduce the risk of buprenorphine misuse. Dr. George Bigelow and colleagues evaluated the formulation with five patients, two men and three women aged 33 to 42, who had been using heroin more than 6 years on average and were current daily users. The day before initiating buprenorphine, the researchers administered oral doses of hydromorphone as clinically needed to suppress the patients withdrawal symptoms. The amount of hydromorphone needed to alleviate withdrawal symptoms is an objective measure of opioid dependence severity. The patients average opioid addiction was approximately equivalent to 50 mg/day of methadone. Buprenorphine treatment consisted of a single injection of biodegradable polymer microcapsules containing 58 mg of the medication. During the following 6 weeks a 4-week residential phase and a 2-week outpatient phase researchers assessed the patients for signs of heroin withdrawal and patients rated their withdrawal symptoms using a standard questionnaire. No patient needed additional medication for withdrawal relief. To test sustained-release buprenorphine s power to block the effects of heroin-like opioids, patients received weekly challenge test injections of 3 mg hydromorphone or saline under double-blind procedures. Patients subjective ratings Mean Withdrawal Ratings Long-Lasting Buprenorphine Reduces Withdrawal Symptoms in Heroin-Dependent Patients Pre-Injection Day of various hydromorphone effects such as feeling high, sick, or any effect stood at zero in the first 2 weeks after buprenorphine treatment. Drug effect ratings in subsequent weeks of the study remained low less than 25 on a 100-point scale. Moreover, the buprenorphine formulation appeared to be safe and well tolerated, with no significant side effects or signs of opioid intoxication or respiratory depression. These results suggest that sustainedrelease buprenorphine may prove an appealing and effective treatment option for opioid-addicted patients and their physicians. Source Injection Day Withdrawal Suppression Self-Report Ratings Week 1 Week 2 Week 3 Week 4 A new long-lasting, sustained-release form of buprenorphine given by a single injection reduced patients heroin withdrawal symptoms for 4 weeks after treatment. Sobel, B.F.; Sigmon, S.C.; Walsh, S.L.; Johnson, R.E.; Liebson, I.A.; Nuwayser, E.S.; Kerrigan, J.H.; and Bigelow, G.E. Open-label trial of an injection depot formulation of buprenorphine in opioid detoxification. Drug and Alcohol Dependence 73(1):11-22,

6 Research Findings Volume 19, Number 3 (September 2004) Successful Trial Caps 25-Year Buprenorphine Development Effort By Arnold Mann, NIDA NOTES Contributing Writer Twenty-five years ago it would have been almost impossible to imagine a treatment for opiate addiction that could be prescribed in a physician s office, picked up at a pharmacy, and taken at home. But that scenario has been achieved after a quarter-century of collaborative effort and the overcoming of several barriers by NIDA s medication development program and Reckitt Benckiser Pharmaceuticals, Inc. Dr. Don Jasinski, a scientist at NIDA s Intramural Research Program (IRP), was the first to recognize the characteristics of buprenorphine developed in the 1970s as an injectable pain medication as useful for addiction treatment. He led the initial 1978 study demonstrating the drug s effectiveness and its acceptability to patients as a treatment for opiate dependence. Early on, NIDA scientists realized that medications for addiction not only had to be safe and efficacious, but also had to be available in a form that would be practical for therapeutic use over the long term. NIDA worked with Reckitt Benckiser (then Reckitt & Colman) to develop noninjectable formulations of buprenorphine; by 1990, Dr. Ed Johnson and colleagues at the IRP demonstrated that a solution form of the drug administered under the tongue was safe, effective, and acceptable to patients as an opiate dependence treatment. As with any opioid, however, there were concerns about buprenorphine diversion and the potential for abuse. NIDA again collaborated with the manufacturer, and by the mid-1990 s, developed a combination tablet of buprenorphine and naloxone that would minimize the potential for abuse a development that put the vision of take-home treatment for opiate dependence within reach. In the next decade, scientists at NIDA and Reckitt Benckiser conducted clinical trials with more than 2,400 patients that established buprenorphine s safety and efficacy in treating opiate dependence. And finally, a NIDAfunded collaborative clinical trial, codirected by Dr. Paul Fudala of the Veterans Affairs Medical Center and the University of Pennsylvania in Philadelphia, established the safety and effectiveness of the buprenorphine-naloxone combination as a prescribed take-home treatment. Data from this study and two other pivotal trials formed the basis for the U.S. Food and Drug Administration s (FDAs) approval of buprenorphine and the combination medication in Buprenorphine and Buprenorphine/Naloxone Help Patients Quit Opiate Abuse Percent of Tests Opiate-Free 25% Bup 17.8 Bup/Nal Treatment Group 5.8 Placebo Patients undergoing treatment for opiate addiction who received buprenorphine or buprenorphine plus naloxone were more likely to test negative for opiate abuse than patients given placebo. Craving for opiates also was reduced in the two treatment groups. People at NIDA knew of the great need to move opiate addiction treatment from the traditional clinic settings to individual physicians offices. But we had to address concerns about diversion and unprescribed use. Drs. Jasinski, Johnson, and Fudala deserve a great deal of credit for their contributions to this collaborative achievement a safe and effective take-home treatment with minimal likelihood for abuse, says Dr. Frank Vocci, director of NIDA s Division of Treatment Research and Development. Dr. Fudala s research, a nationwide study of 472 opiateaddicted men and women, was codirected by Dr. T. Peter Bridge, then of NIDA, and was recently published. The study confirmed that the efficacy and safety of the combined therapy are equivalent to those of buprenorphine alone and superior to placebo. The combination reduces craving for and use of opiates, presents limited potential for abuse, and is suitable for office-based use, the investigators concluded. 2

7 Initial Treatment Outcomes The study began with a double-blind phase in which 323 opiate-addicted individuals (ages 18 to 59) received one of three treatments for 4 weeks. One group of 109 patients received tablets totaling 16 mg buprenorphine and 4 mg naloxone; the second group (105 patients) received tablets totaling 16 mg buprenorphine only; and the third group (109 patients) received placebo tablets. All tablets were identical in appearance and taste. Patients reported to the clinics for dosing every weekday and took their medications home for weekends and holidays. Study patients and placebo patients also participated in up to 1 hour of individualized counseling per week. Opiate use was monitored through urine tests every Monday, Wednesday, and Friday. The plan for the initial double-blind, 4-week arm of the study was to recruit 384 patients and provide each patient with 4 full weeks of therapy. However, recruitment was halted at 323 subjects because the patients receiving either medication clearly were doing better than the placebo patients. Both medication groups showed significant reductions in opiate use and craving and significant improvements in perceptions of overall health compared with those receiving placebo. In the buprenorphine-naloxone group, the proportion of opiate-free tests was 17.8 percent; the buprenorphine group had 20.7 percent opiate-free tests; and the placebo group, 5.8 percent. The presence of cocaine, the nonopiate drug most commonly found in urine samples in this study, did not vary significantly among the three groups. Nor was there a noticeable difference among the treatment groups in drug-positive results for amphetamines, barbiturates, or methadone. The number of urine samples negative for drugs probably would have been higher if investigators had used the results to counsel patients. Such feedback is known to further reduce patients drug use, but that information was not revealed to the researchers to prevent bias. The urine test results reflect higher use at the beginning of the study when patients are ambivalent about treatment and in the grip of addiction. It s positive that opioid use decreased over the course of the study, says Dr. Vocci. Patients in both medication groups also reported reduced craving for opiates. All groups showed the same average self-reported craving level before treatment approximately 60 on a 100-point scale. By week 4 of the study, the average craving scores fell by half for both medication groups but did not change for the placebo group. Patients receiving medications reported greater improvement in overall health and well-being than those in the placebo group perceptions confirmed by higher weekly clinician ratings of patients overall health and well-being for the two buprenorphine-treated groups. Because both medications were clearly effective, the researchers halted the first phase of the study. Patients receiving placebo during this phase went on to receive buprenorphine-naloxone combination treatment in the second phase of the study. Longer-term Efficacy The goal of the study s second phase was to evaluate the safety of the combination tablet in more natural conditions and over a longer term, without the restrictions associated with the double-blind condition. In this open-label portion of the study, which lasted up to 52 weeks, all patients received the combination tablet. Weekly counseling was available along with a daily dose of up to 24 mg buprenorphine and 6 mg naloxone, tailored to each patient s individual response. The sublingual tablet was administered at the clinic each weekday for the first 2 weeks; after that, patients could take home up to a 10-day medication supply at the discretion of the investigator. Of the 472 patients who began this phase of the study, 385 received at least 8 weeks of treatment, and 261 were treated for at least 6 months. Fourteen patients discontinued therapy because of adverse events, of which detoxification or withdrawal symptoms were the most common. Opiate-free urine samples in the open-label phase of the study ranged from 35.2 percent to 67.4 percent in multiple assessments. The overall rate of opiate use was lower than in the first phase of the study, but cocaine and benzodiazepine use remained relatively constant, the researchers reported. The study concluded that the addition of naloxone to protect against illicit use of the treatment medication did not reduce the efficacy of buprenorphine. This new treatment option is historic, says Dr. Vocci. Congress passed the Drug Abuse Treatment Act of 2000 so that buprenorphine products, and other Schedule III, IV, and V medications approved for opioid treatment by FDA, can be prescribed by qualified doctors for the treatment of opioid addiction. This represents a change to a level of prescribing privileges that American doctors have not had since the Harrison Narcotic Act of Who Can Benefit In the two years since the medication was approved, clinicians have gained an understanding of which patients are most likely to benefit from a take-home treatment option. Dr. Fudala cautions that buprenorphine is not likely to work well for every patient. Those less likely to benefit may include patients who require very high doses of methadone. Buprenorphine is a partial agonist, which means that in severely addicted people, it may not provide enough opiate agonist activity to treat them adequately. 3

8 Dr. Fudala says the combined agent may be especially useful for patients who do not have extremely high levels of addiction and for younger individuals, who typically have a shorter abuse history and may be using smaller amounts of an addictive substance. We re seeing younger and younger heroin addicts these days, says Dr. Fudala. It may be a good initial treatment for them, either as a medical detoxification or, if necessary, as a longer term treatment. We ll have a better understanding of this as we gain more experience. Another suitable population may be addicted professionals, including those in health care, who could be motivated to seek treatment in the privacy of a physician s office setting. Buprenorphine s suitability for office-based prescribing is based on its pharmacologic profile. Like methadone, buprenorphine activates opiate receptors, but its effects level off as the patient takes higher and higher doses; this reduces the likelihood of dangerous side effects such as severe respiratory depression. The addition of naloxone reduces the potential for abuse by illicit injection: If a combination tablet is crushed and injected by a heroin-addicted individual in an attempt to intensify buprenorphine s euphoric effect, naloxone kicks in to induce the symptoms of opiate withdrawal. Finally, buprenorphine has a relatively long duration of action and causes comparatively mild withdrawal discomfort on cessation, affording flexibility in dosing regimens and a margin of convenience for patients and physicians. As of March 2004, 3,951 U.S. physicians were eligible to prescribe buprenorphine. Of that group, 2,848 were granted waivers of a Federal requirement for previous experience in addiction medicine. This number is growing, according to Dr. Vocci. We had estimated that about 6,000 physicians would eventually take the training and get the waiver. So we re at about 50 percent, he says. At this time, he notes, certified physicians are restricted to treating no more than 30 patients. In October 2005, 3 years from the approval of the new drug combination, the Department of Health and Human Services and the Drug Enforcement Administration will evaluate the program and possibly adjust the restrictions. The overall picture, however, is positive, says Dr. Vocci. Very little diversion has been reported with this new combination, he says. Source Fudala, P.J., et al. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. New England Journal of Medicine 349(10): ,

9 Research Findings Volume 19, Number 1 (April 2004) Researchers Adapt HIV Risk Prevention Program for African-American Women By Jill Schlabig Williams, NIDA NOTES Contributing Writer Injecting Drug Users Crack Cocaine Users The HIV/AIDS epidemic has taken a disproportionate toll on racial and ethnic minority populations, especially women. In its surveillance report on the number of Americans living with HIV/AIDS in 2002, the Centers for Disease Control and Prevention estimates that among women with HIV/AIDS, non-hispanic African-American women outnumbered non-hispanic white women by three to one a racial disparity not found among men. African-American drug-using women were addressed in two recent studies by NIDA-funded researchers in Atlanta. Dr. Claire E. Sterk of Emory University, Dr. Kirk W. Elifson of Georgia State University, and colleagues developed and tested gender-tailored, culturally specific adaptations of a standard NIDA HIV prevention intervention. They found that female African-American injecting drug users (IDUs) and crack cocaine users who received either of two targeted 4-week prevention programs reduced their risk behaviors related to drug taking Tailored Interventions Build on NIDA Intervention To Help Drug-Using Women Reduce HIV Risk Behavior in Past 30 days Number of days injected powder cocaine Number of days injected heroin Percentage who traded sex for drugs Mean number of days crack used Percentage who had vaginal sex with one or more paying partners NIDA Standard Intervention Group Baseline Six-Month Followup Motivation Intervention Group Baseline Six-Month Followup African-American drug-using women in three intervention groups reduced behaviors that heightened their risk of HIV infection. However, women receiving the culturally specific, gendertailored motivation and negotiation interventions generally reported greater reductions in risky behaviors after their participation than women in the NIDA standard intervention. and sex more than did women who received the standard intervention. These studies are examples of research that is responsive to community needs, says Dr. Dionne Jones of NIDA s Center on AIDS and Other Medical Consequences of Drug Abuse. When it comes to designing a prevention program, it s not one-size-fits-all. You have to consider social context, be culturally sensitive and appropriate, and tailor your message to the group. Negotiation Intervention Group Baseline Six-Month Followup The researchers goal was to develop culturally appropriate programs grounded in the reality of the daily lives of women most at risk and the difficulties they face in their individual, social, family, and sexual relations and activities. We worked hard to develop interventions with input from this target population, deliver the interventions in a setting where they feel comfortable, and involve them in planning, implementing, and evaluating the interventions, says Dr. Sterk. Over 1 year, using one-on-one interviews and small focus groups, the researchers sought to define the key issues in the women s lives and identify ways to address those issues, including such factors as gender dynamics, economic stressors, gender-specific norms and values, and power and control. Two interventions came out of this research phase. One, a motivation intervention, was designed to motivate the participants to change 5

10 their behavior. The other, a negotiation intervention, recognized that women may fear verbal or physical abuse if they propose safer sex or safer needle use and thus sought to strengthen their negotiation and conflict-resolution skills. Our goal in the motivation intervention was to reduce risk based on what s realistic in the context of the participant s life, explains Dr. Sterk. We worked with the women to set short- and long-term goals, celebrate successes, analyze failures, and identify and overcome barriers. The negotiation intervention recognizes that many of the women s challenges dealt with the need to resolve conflict and that negotiation skills are key to reducing risk. Once the interventions were ready, more than 300 African-American women ages 18 to 59 years 68 IDUs and 265 crack cocaine users were enrolled in the studies. All were HIV-negative and heterosexually active. The women were randomly assigned to one of the three interventions. The NIDA standard intervention was delivered in two one-on-one sessions; the motivation and negotiation interventions each involved four one-on-one sessions. (See textbox, below, for descriptions of each intervention.) At the 6-month followup, both IDUs and crack cocaine users in all three groups reported lower levels of drugusing behavior and risky sexual behaviors than they had reported before receiving the interventions. Reductions were greater among women who received the tailored interventions. Injecting Drug Users. The motivation and negotiation interventions were equally effective in reducing the incidence of needle and injection-works sharing. At 6 months, there was no sharing of drug injection paraphernalia in these groups; in the standard intervention group, 13 percent reported sharing needles and 18 percent reported sharing injection works. Although women in all intervention groups reduced their number of injections over time, only those in the tailored interventions reported statistically significant decreases. Participants in the motivation intervention were most likely to attend drug treatment, whereas women in the negotiation intervention reported more changes in their sexual behavior than did women in other interventions. Crack Cocaine Users. All three interventions were associated with a drop in crack use in the 30 days preceeding followup. About 40 percent of the women in each group reported no use during that period. Among those still abusing crack at followup, women in the motivation intervention were more likely to have reduced their use of crack in risky settings, such as outside or in a crack house, hotel room, or car. Women in the standard and motivation intervention groups significantly decreased the number of paying partners for vaginal sex and the frequency of sex with paying partners. Dr. Sterk suggests that the study s results show it may be optimal to create an intervention that combines skills taught in both the negotiation and motivation Protocols for Standard, Motivation, and Negotiation Interventions All interventions include discussion of the local HIV epidemic, sex and drug-related risk behaviors, safer sex and drug use, and HIV risk-reduction strategies. The two tailored interventions also include a discussion of the impact of race and gender on HIV risk and protective behaviors. The NIDA standard intervention is an HIV/AIDS education program that was developed in the early 1990s. It builds on standard HIV testing and counseling developed by CDC and adds discussion of the principles of HIV prevention for drug users and their sex partners. The intervention involves testing, counseling, and educating participants through use of cue cards on such topics as the definition of HIV/AIDS, who is at risk, and ways to reduce risk. Also offered are demonstrations on condom use and equipment-bleaching techniques for IDUs. Referrals to counseling and other services are provided. The motivation intervention follows the format of the standard intervention for the first session but ends with asking participants to consider what they are motivated to change in their lives. During the second session, this list is reviewed and short- and long-term goals are set. The third and fourth sessions involve discussion of experiences with behavior change, including the woman s sense of control and feelings of ambivalence about behavior change. Riskreduction messages tailored to the participant s level of readiness to change are also delivered in the fourth session. The negotiation/conflict-resolution intervention also follows the NIDA standard intervention for the first session, but it ends with a discussion of intended behavior changes. The second session reviews the list of possible behavior changes and the level of control the participant believes she has and introduces general communication skills and strategies to develop assertiveness. Short-term goals are set for strengthening communication, gaining control, and developing assertiveness. Negotiation and conflict-resolution strategies are introduced during the third session and tailored to the individual during the final session. 6

11 interventions. While participants in the negotiation intervention were generally more successful at reducing sexual risk behaviors, including decreasing the number of paying partners and increasing condom use with steady partners, participants in the motivation intervention had more success at changing drug-use behaviors. Efforts were also made to assist program participants in their lives outside of the program, with success extending well beyond the study s parameters, notes Dr. Sterk. A lot of the women who received the one-on-one support available through the tailored interventions said the program served as a re-entry into society. For example, they were encouraged to obtain a photo ID. Many reported that this simple act made them feel more connected to society again, part of the larger world. Program graduates returned to school, earned their GED, found jobs, joined the project to become counselors or interviewers, and stopped using drugs. Over and over, researchers are finding that we need to take a more holistic approach to intervention programs, says NIDA s Dr. Jones. We can t just focus on drugs and sex. We must look at the big picture. It involves childcare, education, employment, housing, and job training. Community stakeholders need to develop programs that address multiple needs. The project maintained a high retention rate 96 percent of the women enrolled in the studies completed the 6-month followup interview. Dr. Sterk attributes this success to the fact that the project was grounded in the community and to the value of involving community consultants residents, both former drug users and others, who played key roles in recruiting, interviewing, and counseling participants. In future research, Dr. Sterk intends to examine the costeffectiveness of various intervention formats. It appears that individual sessions may be more desirable and costeffective, she predicts. Dr. Sterk would like to continue the research, assessing the long-term effects of specific interventions. She wants to develop an intervention that focuses on women s households, targeting both the woman and her main partner, and she is interested in capacitybuilding translating her research into other settings and training people to develop similar programs in more communities. Sources Sterk, C.E.; Theall, K.P.; and Elifson, K.W. Effectiveness of a risk reduction intervention among African American women who use crack cocaine. AIDS Education and Prevention 15(1):15-32, Sterk, C.E.; Theall, K.P.; Elifson, K.W.; and Kidder, D. HIV risk reduction among African-American women who inject drugs: A randomized controlled trial. AIDS and Behavior 7(1):73-86, Principles That Guide Format, Content of Interventions The interventions used by Dr. Sterk and her colleagues in this study are firmly based in theoretical research. The researchers conducted a series of one-on-one interviews and focus groups with the target population. These interviews yielded the following key principles that guided both the format and the content of the interventions. Offer counseling sessions on an individual basis. It was very clear that women wanted to start with one-onone sessions, says Dr. Sterk. HIV risk behaviors involve so many private, personal issues previous abuse experiences, actions to support their drug habits, things they d never before discussed. They found it easier to discuss these experiences with one person, not a group. Adopt a holistic approach. Along with this research project, a clothing fair was conducted and clothes made available to program participants. Food for breakfast was provided; daycare was close by; and ongoing services, such as help preparing for job interviews, were provided. Make programs community-based. The project was headquartered in a house in the community, which was key to participants convenience and comfort. Researchers also found it important for the women to link participation in this project to local social and health services, including local drug treatment, daycare centers, health services, and other community-based organizations. Community consultants played a key role in the project. Address women s multiple social roles in the intervention. Participants insisted that they didn t want to be labeled simply as drug users. Instead, they wanted the social context of their daily lives to be addressed, including their roles as mothers and steady partners. 7

12 Research Findings Volume 17, Number 6 (March 2003) New Approaches Seek To Expand Naltrexone Use in Heroin Treatment By Robert Mathias, NIDA NOTES Staff Writer Naltrexone, an opiate treatment medication, is used to help patients make the transition from illicit opiate use to a drug-free life. Patients in naltrexone treatment are first detoxified from their dependence on opiates and then take thrice-weekly doses of naltrexone and participate in weekly group therapy sessions. The medication provides a safety net for patients because it blocks the euphoric effects they normally would feel if they slip and use heroin or any other opiate. As a result, even relapse, which is common in addiction treatment, may have a therapeutic effect as repeated failure to get high may eventually break the neurobiological and behavioral links between taking drugs and the rewards that lead patients to resume regular drug use. With successful naltrexone treatment, slips to drug use become less frequent, the medication is discontinued, and patients continue behavioral treatment if needed. Naltrexone treatment has been successful mainly with patients who are highly motivated to stop using opiates. Such patients include health care professionals who must stop using opiates to retain their licenses to practice medicine and individuals subject to criminal justice sanctions for relapse to illicit opiate use. The severe penalties that these patients would incur if they fail treatment enable them to overcome naltrexone s main drawback: It eliminates the powerful rewarding effects of opiates without any replacement to help patients cope with lingering effects of withdrawal. Naltrexone s lack of a reinforcing effect has made it an unattractive treatment option for other patients who lack a strong external incentive to stop using drugs and do not want to go through detoxification and withdrawal from opiates. Most of these patients opt for treatment with medications such as LAAM and methadone, both of Subjects Remaining in Treatment 100% Voucher Incentives Increase Retention In Naltrexone Treatment 1 Standard Naltrexone Only Standard Naltrexone + CM (Contingency Management) Standard Naltrexone + CM + SO (Significant Other Involvement) Treatment Week Source: Archives of General Psychiatry, August In a study with 127 heroin-addicted patients receiving naltrexone therapy, the 12-week dropout rate was about 50 percent among those in two groups that received voucher-based contingency management, and about 75 percent among those who did not. 7 which help them to cope with the absence of the intense and rapid high that they are accustomed to getting from heroin by replacing it with a more moderate, stabilizing effect that can help them to maintain a nonaddicted lifestyle. Despite its limited clinical use, naltrexone has many qualities that make it an attractive option for treating a broader range of opiate-dependent patients. It is not addicting, has few adverse effects, can be prescribed without concerns about diversion to the illicit drug market, and is not subject to the restrictive regulatory requirements that limit the use of methadone and LAAM to specialized clinics. Thus, like the recently approved opiate treatment medication buprenorphine, naltrexone can be administered in many settings, including private physicians offices, making it more attractive to individuals who are reluctant to enter clinics

13 Naltrexone s desirable therapeutic traits have continued to spark interest in finding new ways to expand its usefulness and application in practice. Two recent studies show that adjunctive behavioral and new pharmacological approaches may help to increase naltrexone s effectiveness for a wider range of opiate-addicted patients. Voucher Reinforcement Increases Naltrexone s Effectiveness A NIDA-supported treatment study that rewarded heroindependent patients with vouchers whenever they took their naltrexone or tested negative for drug use has found that this basic behavioral reinforcement approach achieved significantly better results than standard naltrexone treatment alone in keeping patients in treatment longer, having them complete treatment, and reducing their opiate use. A significant boost in treatment adherence was achieved not with highly motivated patient groups that have generally responded well to naltrexone treatment, but with predominantly unemployed street addicts, most of whom had a history of extensive involvement with drug abuse treatment and the legal system, says Dr. Dorynne Czechowicz of NIDA s Division of Treatment Research and Development. She also maintains that the results are Long-Lasting Formulation Also May Increase Naltrexone Compliance NIDA-supported researchers have been testing a long-lasting depot formulation of naltrexone that is aimed at reducing the three-times-a-week frequency with which patients must now take the medication to prevent them from getting high if they use heroin. The formulation is packaged in microcapsules injected under the skin that slowly release medication for several weeks. The sustained release of naltrexone is meant to maintain enough medication in the patient to suppress heroin s euphoric effects for an extended time. Clinical trials now under way are assessing the safety and efficacy of depot naltrexone. In a recent trial, Dr. Sandra D. Comer and a team of researchers from the New York State Psychiatric Institute and Columbia University tested depot naltrexone in an 8-week inpatient study with 12 heroin-dependent subjects to see how long the medication remains active in the human body and blocks heroin s effects. After detoxification, six patients received a low dose (192 mg) and six received a high dose (384 mg) of the medication. Patients in both groups subsequently were given a placebo or intravenous heroin once a day from Monday through Friday for 6 weeks. Each week, daily doses of heroin started at 6.5 mg and increased to 12.5, 18.75, and 25 mg; the placebo was administered randomly on one of the days. Researchers assessed subjective, performance, and physiological effects after each dose of heroin or placebo and measured plasma levels of naltrexone over the course of the study. They found that both doses of depot naltrexone substantially suppressed the patients ratings of heroin s pleasurable effects and how much they liked the drug and wanted to take it again. With the high dose of naltrexone, patients positive ratings of heroin s pleasurable effects remained low for 5 weeks. In the 6th week, ratings increased significantly relative to week one after patients received the and 25-mg injections of heroin. The low dose suppressed positive ratings of heroin for 3 weeks. Plasma levels of naltrexone remained above 1 ng/ml for 4 weeks with the high dose and 3 weeks with the low dose. Though these levels are low compared to those resulting from standard naltrexone treatment doses, other studies have reported that even with negligible plasma levels, naltrexone continues to counter heroin s effects. Other than initial discomfort at the site of naltrexone injection, there were no untoward side effects. The results suggest that once-a-month administration of the depot formulation can provide safe, long-lasting blockade of the effects of intravenous streetlevel heroin doses in patients who have undergone detoxification. Future studies will address questions that remain about optimal dose levels for naltrexone treatment of heroin dependence, such as what effects different doses have on withdrawal, craving, and the ability to reduce heroin use. Source Comer, S.D., et al. Depot naltrexone: Long-lasting antagonism of the effects of heroin in humans. Psychopharmacology 159: ,

14 promising for expanding the types of patients who would benefit from naltrexone treatment. The 12-week study, led by Dr. Kathleen Carroll of the Yale University School of Medicine, randomly assigned 127 recently detoxified opioid-dependent patients to 1 of 3 treatment conditions: standard treatment with naltrexone 3 times a week; standard naltrexone treatment plus a behavioral reinforcement approach called contingency management (CM); or standard naltrexone treatment and CM plus involvement of a significant other (SO) in up to 6 family counseling sessions. SO treatment was added to CM for patients in the third group to test the idea that encouragement and positive reinforcement from a significant other might help patients cope with any protracted drug withdrawal symptoms and remain in treatment longer. Patients in all three groups participated in weekly cognitive-behavioral group counseling sessions. Patients in the CM groups could earn vouchers, which they could exchange for goods and services, in separate tracks for naltrexone compliance or drug-free tests. In each track, the voucher value started at $0.80, escalated in $0.40 increments for continuous compliance or abstinence, and were reset to the starting point for each failure to take the medication or pass a drug test. Over the course of the study, patients in the CM groups earned an average of $189 in vouchers out of the maximum $561 that could be earned for perfect medication compliance and all negative drug tests. The researchers found that on average, patients in the two CM groups stayed in treatment 7.4 weeks, significantly longer than the 5.6 weeks for those in standard treatment. A much higher percentage of CM patients also completed the full 12-week treatment period 47 percent of CM plus SO patients, 42.9 percent in the CM group, and 25.6 percent of patients in the standard treatment group. These retention rates with CM added to standard treatment also compare favorably with rates achieved in previous studies of standard naltrexone treatment, which have reported that 60 to 70 percent of patients dropped out of treatment over a 12-week period, Dr. Carroll notes. Patients in the CM groups also had significantly better treatment outcomes than those in the standard naltrexone group more days of abstinence, longer periods of continuous abstinence, more opiate-free tests, and a higher percentage of drug-free specimens. Additional analyses suggested CM patients made greater reductions than standard treatment patients in the frequency with which they used opiates as the study progressed. Thus, 100 percent of patients reported weekly opioid use at the beginning of the study, but fewer than 10 percent of those who completed treatment reported weekly use over the last 4 weeks of the study. Although adding SO to CM did not improve most treatment outcomes, further analysis suggested it did produce a significant reduction in family problems over time. Our study shows you can really bump up medication compliance and outcomes with very simple behavioral interventions, Dr. Carroll says. It doesn t take much effort or cost for treatment programs to do this, particularly if you look at the potential savings from keeping patients in treatment longer where they can learn how not to be drug users. Source Carroll, K.M., et al. Targeting behavioral therapies to enhance naltrexone treatment of opioid dependence: Efficacy of contingency management and significant other involvement. Archives of General Psychiatry 58(8): ,

15 Research Findings Volume 17, Number 5 (January 2003) Opening the Door to Mainstream Medical Treatment of Drug Addiction By Glen R. Hanson, Ph.D., D.D.S., NIDA Acting Director The October approval of buprenorphine by the U.S. Food and Drug Administration for treatment of opiate dependence marks a historic milestone for drug abuse research and treatment. Buprenorphine crowns more than two decades of NIDA-supported research on the neurobiology of drug addiction with a medication that has the potential to increase the safety, availability, and acceptance of opioid abuse treatment in the United States. As the first medication for opioid maintenance treatment that physicians can dispense in their offices to patients addicted to heroin and prescription pain relievers, buprenorphine creates a new therapeutic option whose convenience and relative privacy should appeal to many patients and may facilitate the integration of drug abuse therapy with attention to patients other medical needs. Buprenorphine s availability culminates the collaborative efforts of NIDA s medication development program and the pharmaceutical division of the firm Reckitt Benckiser. Over the last decade, these entities conducted clinical trials with more than 2,400 patients that established buprenorphine s safety and efficacy in treating opiate dependence. At the same time, Federal legislators enacted the Drug Abuse Treatment Act of 2000 (DATA), which removed numerous regulatory barriers to the use of approved opiate treatment medications in doctors offices. More than 2,000 physicians already have qualified under DATA to use buprenorphine in their practices. Buprenorphine s distinctive pharmacology gives it the safety margin and low potential for diversion to illicit use required for office-based use. Buprenorphine s distinctive pharmacology gives it the safety margin and low potential for diversion to illicit use required for office-based use. The medication s unique mechanism of action how it works to achieve its therapeutic effect and reduce the likelihood it will be abused is grounded in decades of basic and clinical research on the biological and behavioral underpinnings of drug addiction. Using fundamental knowledge derived from NIDA-funded research about where and how opiates such as heroin work to achieve their euphoric effects, NIDA researchers identified buprenorphine as a potential opiate treatment medication in the late 1970s. Subsequent research with the compound showed that it interacts in similar but significantly different ways at the same mu opioid receptor in the brain where heroin, morphine, and prescription pain relievers as well as the treatment medication methadone initiate their effects. As a partial agonist at this receptor, buprenorphine blocks heroin s effects, reduces cravings for the drug, and prevents unpleasant withdrawal symptoms. Moreover, its potential for abuse is limited because it produces less stimulation and physical dependence than full agonist medications, such as methadone, and its euphoric effect peaks at a moderate level no matter how much is taken. NIDA s medications development program further refined buprenorphine by developing two formulations for use at different stages of treatment for opiate addiction. Patients generally will make the transition from illicit opiate drugs to Subutex a medication containing only buprenorphine in a few days under their physician s direct supervision when they begin treatment. Once they adjust to Subutex, patients will be switched to Suboxone, which contains buprenorphine and an opiate antagonist called naloxone. This combination of ingredients further reduces the medication s potential for illicit injection; if a Suboxone tablet is crushed and injected in an attempt to accelerate and intensify buprenorphine s agonist effects, naloxone blocks the mu receptor and can induce opiate withdrawal. Suboxone will be the main prescription medication 11

16 patients take home for long-term treatment of the physiological changes wrought by chronic opiate abuse, for use in conjunction with counseling and support services to help them live stable, productive lives. Office-based treatment with buprenorphine will give clinicians a powerful new tool to treat opiate addiction; it will not replace medications now used to treat this disorder. Much research and clinical experience has shown that methadone, administered regularly in a comprehensive treatment program, can reduce or eliminate heroin injection and the attendant risk of AIDS and other infectious diseases. A longer lasting form of methadone, LAAM (the first medication developed by NIDA s medication development program) gives clinicians additional flexibility in managing opiate dependence. As full agonists at the mu opioid receptor, both methadone and LAAM address heroin s harmful effects but also produce strong physical dependence and, compared to buprenorphine, have a higher potential for abuse and greater danger of overdose. As a result, they remain subject to strict Federal, State, and Methadone clinics will continue to play a crucial role in treating heroin addiction, but they are able to treat only one-fifth of the estimated 1 million Americans who are dependent on opiates. local regulations that limit their use to licensed narcotic addiction treatment clinics. Methadone clinics will continue to play a crucial role in treating heroin addiction, but they are able to treat only one-fifth of the estimated 1 million Americans who are dependent on opiates. Office-based treatment with buprenorphine will help fill this treatment gap by providing more treatment options for the 800,000 opiate-addicted individuals not now being treated. People who abuse heroin or prescription pain medications but have avoided methadone clinics because of the stigma associated with them, and likewise, adolescents and young adults who have become addicted to heroin through snorting the drug are among the prospective new patients expected to get the medical help they need from their physicians. In addition, some stable methadone patients may transfer from clinic care to office-based treatment to eliminate the burden of daily methadone clinic visits. As a result of such transfers, methadone treatment slots will open up for the many heroin abusers waiting to enter treatment. The public-private initiatives that have made it possible for patients to be treated with buprenorphine in their doctors offices are based on scientific understanding of drug addiction as a chronic, relapsing brain disease that can be treated medically as we treat other chronic diseases, such as diabetes or hypertension. Office-based treatment with buprenorphine advances the day when all distinctions between drug abuse and other medical treatment disappear and primary care physicians and treatment professionals work together to provide patients with the most effective medications and psychosocial treatments available for their disease. 12

17 Research Findings Volume 17, Number 4 (November 2002) Buprenorphine Approval Expands Options for Addiction Treatment Roughly two decades of NIDA-sponsored research and clinical trials have culminated in the Food and Drug Administration s (FDA) approval of buprenorphine as a treatment for opiate dependence and addiction. The medication was developed through a Cooperative Research and Development Agreement between NIDA and the firm Reckitt Benckiser, Inc. Buprenorphine and the combination buprenorphine/ naloxone are the first medications approved under the Drug Abuse Treatment Act of 2000 (DATA), which allows for office-based treatment of opiate addiction. Under the terms of DATA, physicians providing treatment must complete special training to dispense the medications, must agree to treat no more than 30 patients at a time in an office setting, and must refer patients to appropriate counseling and support services to enhance pharmacological treatment. The FDA action will permit physicians to prescribe buprenorphine as part of office-based practice, making it possible for patients dependent on heroin or prescription We are hopeful bupenorphine will be the first of many new drug addiction medications eligible for use under the Drug Abuse Treatment Act of 2000 legislation. Senator Orrin Hatch (R-Utah), coauthor of DATA. Approval of this new drug will allow for the long-awaited and appropriate conventional, office-based approach to addiction treatment in this country. Senator Carl Levin (D-Michigan), coauthor of DATA. painkillers such as OxyContin to receive treatment in their doctors offices rather than requiring daily visits to a centralized methadone clinic. Patients entering or continuing treatment in clinic settings would also be eligible to receive the new medications. The availability of an effective medication that can be provided in an office-based setting will significantly increase the number of patients receiving treatment, according to Dr. Frank Vocci, director of NIDA s Division of Treatment Research and Development. Nearly 1 million Americans are dependent on opiates, but only 200,000 of them are getting treatment in licensed methadone clinics. Approval of this medication means that many more people who want treatment can get it, Dr. Vocci says. FDA approval of this medication marks a truly great moment in the treatment of drug dependence and addiction, and it clearly shows the value of collaborative partnerships between legislators, Federal agencies, and private industry. Buprenorphine is pharmacologically related to morphine and is a partial opioid agonist it has the same effect on mu opiod receptors in the brain as does heroin or other 13

18 opiate drugs, but it has a lower maximum effect. Buprenorphine reduces or eliminates withdrawal symptoms associated with opioid dependence but is not strong enough to produce the euphoria and sedation caused by heroin or other opiates. Increasing the dose of buprenorphine does not enhance the drug effects, however, so the medication is unlikely to be abused. FDA approved two forms of the medication. Buprenorphine alone will be prescribed (under the trade name Subutex) for patients in the early stages of treatment. Buprenorphine combined with naloxone, an opioid antagonist, will be prescribed (as Suboxone) for long-term maintenance therapy that will allow patients to resume and maintain normal, productive lives during treatment. Combining the antagonist naloxone with buprenorphine further reduces the potential that the medication could be abused; injecting the combined formulation triggers withdrawal symptoms. Subutex and Suboxone will be provided in tablet form as take-home medications. 14

19 Research Findings Volume 17, Number 3 (October 2002) Combining Medications May Be Effective Treatment for Speedball Abuse By Kimberly R. Martin, NIDA NOTES Contributing Writer NIDA-supported researchers from Harvard Medical School-McLean Hospital, in Belmont, Massachusetts, discovered that a combination of the drugs buprenorphine and indatraline reduced the self-administration of speedball by monkeys. Speedball is a cocaine-heroin mixture that is taken by some injecting drug users and may increase the adverse consequences of drug abuse, such as greater severity of psychiatric disorders, higher incidence of failure in drug abuse treatment, and increased risk of contracting HIV infection. Speedball abuse presents special challenges for drug abuse treatment. Cocaine and heroin exert different effects on the brain, and little is known scientifically about how the two drugs interact. Current medications for heroin abuse, such as methadone, are only moderately effective in reducing speedball abuse and at present there are no effective medications for cocaine abuse. Combinations of medications that target the effects of either cocaine or heroin have shown promise in reducing speedball self-administration in preclinical studies. Clinical experience has shown that the most effective medications currently available to treat drug abuse have two distinguishing characteristics, said co-investigator Dr. Nancy K. Mello. First, these medications produce behavioral effects that are similar to the abused drug and minimize or prevent withdrawal symptoms. Second, these medications have a slow onset and long duration of action, resulting in a lower potential for abuse than rapid-onset, short-acting drugs such as heroin or cocaine. Indatraline, a dopamine reuptake inhibitor, and buprenorphine, an opioid mixed agonist-antagonist, each meet both of these criteria. Both drugs have a long duration of action; buprenorphine produces behavioral and physiological effects similar to heroin; indatraline is an experimental drug that produces cocaine-like effects. Dr. Mello and Dr. S. Stevens Negus compared the effects of chronic treatment with indatraline and buprenorphine separately and in combination on speedball self-administration by rhesus monkeys. Five monkeys previously trained to self-administer cocaine were given access to speedball combinations (3:1 ratios of cocaine to heroin), which they began to self-administer more than 70 times a day. Speedball* Injections/Day Indatraline-Buprenorphine Combination Reduces Self-Injection of Speedball by Monkeys Consecutive Days *Speedball: Cocaine heroin mg/kg/inj mg/kg/day mg/kg/day Before treatment with a combination of indatraline and buprenorphine, monkeys injected speedball an average of 66 to 78 times per day. After treatment, speedball self-administration was reduced and the decreases were sustained throughout 10 days of treatment. After 5 days of treatment with the highest dose of the combined medications, speedball self-administration decreased to between zero and five injections per day. Over four 10-day periods, the monkeys were treated daily with saline, with indatraline or buprenorphine alone, and with the indatraline-buprenorphine combination in three increasing concentrations. Saline and the lowest concentration of the combined medications had little effect on speedball self-administration; the highest doses of the combined medications significantly decreased the number of times the monkeys self-administered speedball. By the fifth day of treatment with a combination of indatraline and buprenorphine, speedball injections decreased by more than 90 percent, to fewer than five injections per day in four of the five monkeys studied. The same doses of indatraline or buprenorphine alone did not significantly reduce speedball self-administration. 15

20 The combination of indatraline and buprenorphine not only reduced speedball self-administration, but these effects were sustained across the 10-day treatment period and over a range of doses, says Dr. Mello. These findings underline the importance of exploring medication combinations as a novel approach for treatment of polydrug abuse. Although this study used an animal model, the results are intriguing and suggestive of potential clinical efficacy, said Dr. Jane Acri of NIDA s Division of Treatment Research and Development. There is evidence that buprenorphine can reduce opiate use in humans, but the data supporting the use of compounds such as indatraline for reducing cocaine use by humans are more limited. The selection of a combination mechanism strategy is reasonable; further study is needed to determine the effectiveness of these compounds in the treatment of speedball abuse in humans. Sources Mello, N.K., and Negus, S.S. Effects of flupenthixol and quadazocine on self-administration of speedball combinations of cocaine and heroin by rhesus monkeys. Neuropsychopharmacology 21: , Mello, N.K., and Negus, S.S. Effects of indatraline and buprenorphine on self-administration of speedball combinations of cocaine and heroin by rhesus monkeys. Neuropsychopharmacology 25(1): ,

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